COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso veterinario «Feligen CRP» (16A08119)
Estratto del provvedimento n. 710 del 21 ottobre 2016 Medicinale veterinario FELIGEN CRP. Confezioni: scatola da 10 dosi - A.I.C. n. 101838011;
scatola da 1 dose - A.I.C. n. 101838023;
scatola da 30 dosi - A.I.C. n. 101838035;
scatola da 1 dose + siringa - A.I.C. n. 101838047;
scatola da 50 dosi - A.I.C. n. 101838050. Titolare dell'A.I.C.: Virbac Francia, 1ere avenue - 2065 m - L.I.D., 06516 - Carros (France). Oggetto del provvedimento: numero procedura europea: DE/V/natWS/II/2016/111. Si autorizzano le modifiche ai punti 4.4 e 4.9 dell'RCP del prodotto immunologico in oggetto, al fine di includere la raccomandazione di praticare una terza iniezione, in caso di presenza di anticorpi di origine materna, a partire dalla quindicesima settimana di eta'. Per effetto delle suddette variazioni si modificano i punti 4.4, 4.9 e 10 dell'RCP allegato come di seguito indicato: 4.4 Avvertenze speciali per ciascuna specie di destinazione Anticorpi di origine materna, in particolare quelli contro il virus della panleucopenia felina, possono influenzare negativamente la risposta immunitaria alla vaccinazione. 4.9 Dosi da somministrare e via di somministrazione Il flacone di FELIGEN CRP deve essere ricostituito con l'intero contenuto del flacone di acqua per...
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